Canada urged to accept US, EU drug approvals

If Canada had accepted European Union and US drug approvals instead of “duplicating their processes,” Canadian patients could have gained access to 152 new drugs 494 days earlier, on average, from 2005 to 2011/12, says a new report.

Nearly all newly-patented prescription drugs approved by Health Canada have also been approved by the US and EU, but much earlier, says the study, from free-market think tank the Fraser Institute.

For example, 30 of a group of 31 drugs approved by Health Canada in 2011/12 were approved a median of 386 days early in the US, while in Europe, all 31 were approved a median of 267 days earlier, it says.

Important new cancer drugs, including Genentech/Roche’s Avastin (bevacizumab) and Sanofi’s Jevtana (cabazitaxel) became available to patients in Canada over a year after being approved in either the US or Europe, comments study co-author Nadeem Esmail, director of health policy studies at the Fraser Institute.

“Such needless delay unquestionably had a negative effect on those patients whose lives could have been extended by these drugs,” he added.

Most of the delay in accessing new drugs in Canada resulted from drugmakers submitting their applications for approval significantly later there than in the EU and US, the study finds. Reasons for this may include Canada’s relatively weaker intellectual property protections, small market size and drug pricing controls, plus the extra financial burden associated with additional regulatory hurdles, it suggests.

Given that Health Canada’s drug approval process is not significantly different from those in Europe or the US, there is little justification for forcing patients to wait for access to medicines already approved in the US and Europe, it says.

Relieving Health Canada of its mandatory drug regulation function would not prevent it from providing safety warnings or requiring withdrawal of a drug from the Canadian marketplace, Mr Esmail and his co-author Bacchus Barua point out. Canadian approvals could also be done on a non-mandatory basis, with productss approved in the US or Europe being subjected to a labelling requirement, they add.

More importantly, such an approach would open up new possibilities for Health Canada, they suggest. First, it could provide more support for surveillance of already-approved drugs. Second, funding better communications about prescription drugs and their side effects to both patients and physicians would allow everyone to make more informed decisions, they add.